Outcome-based splinting

ABSTRACT

A bone fracture fixation system including reference pins inserted into bone fragments of a patient in a first configuration and an image capture device configured to capture an image of the reference pins, and the bone fragments. The system includes a processor configured to receive and pre-process the captured image data. The processor pre-processes the image data by virtually re-positioning the reference pins in the first configuration into a second configuration, wherein the re-positioning virtually re-positions the bone fragments into normal alignment; and virtually generating a support device. The system includes a point-of-care production apparatus that produces a three-dimensional model of the virtually generated support device in a form that can be applied to the patient. The three-dimensional support device generated by the point-of-care production apparatus is configured to receive the reference pins in the first configuration; and simultaneously re-positions and fixes the bone fragments into normal alignment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of application Ser. No.16/297,158, filed Mar. 8, 2019, which is hereby incorporated herein byreference for all purposes.

BACKGROUND 1. Field

This disclosure relates generally to digitally-guided reduction andexternal fixation systems for fixing a bone fracture. More particularly,this disclosure relates generally to digitally guided reduction andexternal fixation systems that allow for reduction and fixation of abone fracture in a single step.

2. Description of Related Art

External fixation traditionally entails the use of percutaneously placedpins and/or wires secured to an external scaffolding device to providesupport for a fractured limb. Using this mechanism, a bone or joint canbe stabilized during limb reconstruction. The technique presents manybenefits compared to internal plates and intramedullary nails. Externalfixators cause less disruption of soft tissues, osseus blood supply andperiosteum and are especially ideal for soft tissue management in casesof acute or chronic trauma wherein skin quality is compromised.Additionally, the temporary nature of the pins and wires make framesideal for providing bone stability in cases of infection of the bone,where the presence of internal implants would make treatment of theinfection more challenging. Furthermore, unlike internal plates,external fixators provide postoperative adjustability. External fixationmay also be used in limb lengthening and deformity correctionprocedures.

Fracture management with external fixation involves placing longitudinaltraction across a fractured limb to obtain a closed reduction andmounting a fixator while maintaining the reduction. External fixationdevices are designed to assist in temporarily stabilizing the fractureand may be used for short periods of time until a more permanentsolution is appropriate. Certain devices utilize a pin-to-bar frameconstruct. In utilization, the surgeon places half pins independently insafe corridors of the limb. Separate connecting bars are assembled tothe pins and the bone segments are then manipulated to reduce thefracture. The connecting bars are then connected to one another untilall points of fixation on the bone segment are incorporated.

Conventional external fixation devices require separate reduction andfixation components in the form of multiple connecting bars. Modifiedassemblies capable of reducing and fixating fractures would bebeneficial to simplify the process of external fixation.

SUMMARY

The foregoing advantages of the invention are illustrative of those thatcan be achieved by the various exemplary embodiments and are notintended to be exhaustive or limiting of the possible advantages thatcan be realized. Thus, these and other objects and advantages of thevarious exemplary embodiments will be apparent from the descriptionherein or can be learned from practicing the various exemplaryembodiments, both as embodied herein or as modified in view of anyvariation that may be apparent to those skilled in the art. Accordingly,the present invention resides in the novel methods, arrangements,combinations, and improvements herein shown and described in variousexemplary embodiments.

In light of the present need for a simplified external fixationassembly, a brief summary of various exemplary embodiments is presented.Some simplifications and omissions may be made in the following summary,which is intended to highlight and introduce some aspects of the variousexemplary embodiments, but not to limit the scope of the invention.Detailed descriptions of a preferred exemplary embodiment adequate toallow those of ordinary skill in the art to make and use the inventiveconcepts will follow in later sections.

Various embodiments disclosed herein relate to a digitally-guidedreduction and external fixation system for fixing a bone fractureincluding one or more reference pins configured to be inserted into oneor more bone fragments of a patient in a first configuration and animage capture device configured to capture an image of the one or morereference pins in the first configuration, and the one or more bonefragments. The digitally-guided reduction and external fixation systemadditionally includes a virtual reduction and fixation device includinga processor configured to execute instructions to receive the capturedimage data of the one or more reference pins in the first configuration,and the one or more bone fragments and pre-process the image data. Theprocessor pre-processes the image data by virtually re-positioning theone or more reference pins in the first configuration into a secondconfiguration, wherein the re-positioning of the one or more referencespins into the second configuration virtually re-positions the one ormore bone fragments into normal alignment; and virtually generating asupport device, wherein the support device includes one or moreapertures configured to receive the one or more reference pins in thesecond configuration. The processor then sends a description of thevirtually generated support device to a point-of-care productionapparatus. The point-of-care production apparatus is configured toproduce a three-dimensional model of the virtually generated supportdevice in a form that can be applied to the patient. Thethree-dimensional support device generated by the point-of-careproduction apparatus is configured to receive the one or more referencepins inserted into the one or more bone fragments of the patient in thefirst configuration; wherein the three-dimensional support device isconfigured to simultaneously re-position and fix the one or more bonefragments into normal alignment. In various embodiments, the systemincludes two or more reference pins, wherein the reference pins arethreaded. The reference pins may be manufactured from a radiolucentmaterial, such as a plastic-based material.

In various embodiments, the system further includes one or more scanninglocators attached to the one or more reference pins at a proximal end.The scanning locators may be manufactured from a radiopaque material.

In various embodiments, the system further includes a locking deviceconfigured to fix the three-dimensional support device generated by thepoint-of-care production apparatus to the one or more reference pinsinserted into the one or more bone fragments of the patient in the firstconfiguration.

In various embodiments, the image capture device is an X-ray, MRI, CT,CBCT or ultrasound device. In various embodiments, the point-of-careproduction apparatus is a 3D printing device.

In various embodiments, the virtually generated support device furtherincludes additional apertures that may be added at the discretion of thesurgeon.

Various embodiments disclosed herein further relate to a method ofreducing and fixating a bone fracture including inserting one or morereference pins into one or more bone fragments of a patient in a firstconfiguration; capturing image data of the one or more reference pins inthe first configuration, and the one or more bone fragments; andpre-processing the captured image data using a processor. Thepre-processing step includes virtually re-positioning the one or morereference pins in the first configuration into a second configuration,wherein the re-positioning of the one or more references pins into thesecond configuration virtually re-positions the one or more bonefragments into normal alignment; and virtually generating a supportdevice, wherein the support device includes one or more aperturesconfigured to receive the one or more reference pins in the secondconfiguration. The method additionally involves producing at thepoint-of-care a three-dimensional model of the virtually generatedsupport device in a form that can be applied to the patient; applyingthe three-dimensional support device generated at the point-of-care tothe one or more reference pins inserted into the one or more bonefragments of the patient in the first configuration; and simultaneouslyre-positioning and fixing the one or more bone fragments into normalalignment.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to better understand various exemplary embodiments, referenceis made to the accompanying drawings, wherein:

FIG. 1 is a flow diagram describing the steps of the digitally guidedreduction and external fixation method;

FIG. 2 is a flow diagram illustrating the digitally guided reduction andexternal fixation method;

FIG. 3A illustrates a side view of the reference pins and scanninglocators;

FIG. 3B illustrates the application step of the reference pins andscanning locators to a fractured limb;

FIG. 4 illustrates the image captured during the image capture step ofthe digitally guided reduction and external fixation method;

FIGS. 5A-5D illustrate the virtual reduction and virtual support devicedesign steps of the digitally guided reduction and external fixationmethod;

FIG. 6 illustrates the point-of-care support device production step ofthe digitally guided reduction and external fixation method;

FIG. 7 illustrates the support device application step of the digitallyguided reduction and external fixation method;

FIGS. 8A-8B illustrate different configurations of reference pininsertion into the through holes of the support device; and

FIGS. 9A-9D illustrate different embodiments of locking devices used tosecure the support device to the reference pins;

DETAILED DESCRIPTION

Embodiments described herein disclose a minimally-invasive treatmentworkflow with hardware and software elements for reducing and fixatingbone fractures. Various embodiments combine principles of digitalsurgical planning and external fixation techniques to allow for bonefracture reduction and bone fracture fixation in a single step withoutthe need for utilization of robotics. Various embodiments describedherein further allow for point-of-care production of a patient-specificexternal fixation support device.

Referring now to the drawings, in which like numerals refer to likecomponents or steps, there are disclosed broad aspects of variousexemplary embodiments. FIGS. 1 and 2 diagram the steps of the digitallyguided reduction and external fixation method 100, 200. In a first step110, 210, reference pins 320 are applied to the fractured limb 330 ofthe patient (see also FIGS. 3A and 3B). In a second step 120, 220, thereference pins 320 are captured using a medical image capture device. Ina third step 130, 230, a processor pre-processes the captured image databy virtually re-positioning the reference pins 320 in such a way as toreduce the bone fragments into normal alignment, as shown in FIGS. 5Aand 5B. In a fourth step 140, 240, the processor generates a supportdevice 530, wherein the support device 530 includes a first set ofthrough-holes 531, 532 positioned to accommodate the reference pins 320,321 after virtual fracture reduction. In some embodiments, the supportdevice 530 may contain additional through-holes 533 to accommodateadditional bone fixation pin 570. In a fifth step 150, 250, a supportdevice 530 (see FIG. 6 ) is produced using a point-of-care productionmethod. In a sixth step 160, 260, the support device 530 is applied tothe patient (see FIG. 7 ). The support device 530 is configured to guidethe reference pins 320, 321 to their final position, allowing fracturereduction in the operating room. Additional bone fixation pins 570 maybe applied during the sixth step 160, 260. In a seventh step 170, 270the reference pins 320, 321 and any additional bone fixation pins 570are secured to the support device 530 using a locking device 930.

FIG. 3A provides a side view of the reference pins 320. The referencepins 320 include a proximal end 322 and a distal end 323. A scanninglocator device 310 may be applied to the proximal end 322 of thereference pins 320 to provide an additional locator function for thereference pins 320. In various embodiments, the scanning locator device310 may be applied by pushing or screwing the scanning locator device310 onto the proximal end 322 of the reference pins 320.

In various embodiments, the scanning locator device 310 may bemanufactured from any material that may be captured using an imagecapturing device, such as an X-ray, MRI, CT, CBCT or ultrasound device.In various embodiments, the scanning locator device 310 may bemanufactured from a radiopaque material. Suitable radiopaque materialsinclude stainless steel-, aluminum-, titanium-, silver-, bismuth-, andtantalum-based materials, radiopaque composite materials, such asradiopaque carbon fiber, or combinations thereof.

In various embodiments, the reference pins 320 may also be manufacturedfrom any material that may be captured using an image capturing device.In various embodiments, the reference pins 320 may be manufactured fromany materials capable of being viewed using a medical capture device.Suitable materials include radiopaque and radiolucent materials.Suitable radiolucent materials include plastic-based materials such asPEEK, polysulfone, polycarbonate, glass fiber, graphite fiber,polyetherimide, polyethersulfone, polyphenylsulfone, polyphenylsulfideand combinations thereof. The distal end 323 of the reference pins 320may include a sharpened tip 324 to help facilitate penetration into abone fragment. The shaft portion 325 of the reference pins may bethreaded or unthreaded.

FIG. 3B illustrates the application of the reference pins 320, 321 andscanning locator devices 310, 311 to a fractured forearm bone 330. Ascan be seen in FIG. 4 , the reference pins 320, 321 and scanning locatordevices 410, 411 may be inserted into the fractured bone 430 on eitherside of the fracture 440. FIG. 4 illustrates an image capture 400generated during the medical image capture step 120. The image capture400 may be generated using any suitable medical image capture technique,including X-ray, MRI, CT, CBCT or ultrasound.

FIG. 5A illustrates an embodiment of the virtual reduction step 130conducted using a first image capture 500 generated during the medicalimage capture step 120. In virtual reduction step 130, a processor isutilized to effect a virtual auto-reduction of a fracture 540 using thefirst image capture 500 and statistical bone data 550 to generate asecond image capture 501, shown in FIG. 5B, showing the reduced bone 560and final reference pin positions 561, 562. The processor is configuredto collect data points characterizing the movement of the reference pins320, 321 from first positions 541, 542 to the final reference positions561, 562. The processor is then configured to generate a virtual supportdevice 530 having a first set of through-holes 531,532 configured toaccommodate the reference pins 320, 321 in final reference positions561, 562 as shown in FIG. 5C. The processor is configured to generate avirtual support device 530 that is characterized by a design and contourthat allows for reduction of the fracture 540. In some embodiments, theprocessor may be further configured to allow for the option of virtuallygenerating an additional through-hole 533 to accommodate additional bonefixation pin 570 at the discretion of the user, as shown in FIG. 5D.

In various embodiments, the processor is a hardware device for executingsoftware, particularly that which is stored in memory. The processor maybe any custom made or commercially available processor, a centralprocessing unit (CPU), an auxiliary processor among several processorsassociated with a computer, a semiconductor-based microprocessor (in theform of a microchip or chip set), a macroprocessor, or generally anydevice for executing software instructions.

FIG. 6 illustrates the point-of-care production step 150 wherein thevirtual support device 530 is translated, using a processor and apoint-of-care production device 600, into a three-dimensional supportdevice 530. As can be seen in FIG. 6 , the three-dimensional supportdevice 530 contains a first set of through-holes 611, 612 configured toaccommodate the reference pins 320, 321 and an additional through-hole613 to accommodate additional bone fixation pin 570. The point-of-careproduction device 600 may be a 3-D printer or any other device thatallows for immediate translation of a two-dimensional image to athree-dimensional model. The three-dimensional support device 530, maybe manufactured from any suitable materials of sufficient rigidity tosupport reduction and external fixation of a bone fracture. Suchmaterials include standard plate fixation plate materials, such asplastic materials, metallic materials, and composites. Suitable plasticmaterials include thermoplastic materials including acrylic, ABS, Nylon,PLA, polycarbonate (PC), polyethylene materials and combinationsthereof. Suitable metallic materials include titanium, stainless steeland the like; and suitable composite materials include carbon fiber andthe like.

FIG. 7 shows the application of the three-dimensional support device 530over reference pins 320, 321. The reference pins 320, 321 are insertedinto through holes 730, 731, respectively. In this embodiment,application of the three-dimensional support device 530 reduces andfixates a fracture of the forearm 740. In other embodiments, thethree-dimensional support device 530 may be configured to be applied toreduce and fixate a fracture of any bone of the patient. Thethree-dimensional support device 530 shown in FIG. 7 includes theadditional through-hole 750 configured to accommodate additional bonefixation pin 570.

FIGS. 8A and 8B show embodiments of different insertion configurationsfor the reference pin 320 through through-holes 810, 811. In FIG. 8A,the through-hole 810 is sized to threadably engage the threadedreference pin 320. In FIG. 8B, the reference pin 320 first threadablyengages an insert 830. The reference pin 320 and insert 830 construct isthen inserted into a through-hole 811 sized to accommodate the insert730.

FIGS. 9A and 9B illustrate a first embodiment of a locking device 930configured to secure the reference pin 320 into through-hole 911 ofthree-dimensional support device 910. The locking device 930 isthreadably secured to threaded reference pin 320 at a proximal end 921and rotated in a clockwise direction until a distal end 931 of thelocking device 930 is secured in the through-hole 911, as shown in FIG.9B. More specifically, the locking device 930 contains a threadedportion 931 at a distal end configured to threadably engagecomplementary threads contained on the inner surface of through-hole911.

FIGS. 9C and 9D illustrate an alternative embodiment of a locking device940 configured to secure the reference pin 320 to the through hole 911of the three-dimensional support device 530. The locking device 940includes a locking nut 950 configured to threadably engage the referencepin 320 at a proximal end 921. The locking nut 950 contains a firstgroove 951 and a second groove 952. The locking device 940 additionallyincludes a locking key 960 having a channel 961 configured to slidablyreceive the reference pin 320 and further configured to engage thegrooves 951, 952 of the locking nut 950 at a distal end 962. The lockingkey 960, when turned in a clockwise direction, secures the locking nut950 into the through-hole 911.

Although the various exemplary embodiments have been described in detailwith particular reference to certain exemplary aspects thereof, itshould be understood that the invention is capable of other embodimentsand its details are capable of modifications in various obviousrespects. As is readily apparent to those skilled in the art, variationsand modifications can be affected while remaining within the spirit andscope of the invention. Accordingly, the foregoing disclosure,description, and figures are for illustrative purposes only and do notin any way limit the invention, which is defined only by the claims.

What is claimed is:
 1. A method of reducing and fixating a bone fracture comprising inserting one or more reference pins into one or more bone fragments of a patient in a first configuration; capturing image data of the one or more reference pins in the first configuration, and the one or more bone fragments, pre-processing the captured image data using a processor by virtually re-positioning the one or more reference pins in the first configuration into a second configuration, wherein a re-positioning of the one or more reference pins into a second configuration virtually re-positions the one or more bone fragments into normal alignment; virtually generating a support device, wherein the support device comprises one or more apertures configured to receive the one or more reference pins in the second configuration and the support device is configured to simultaneously achieve reduction and long-term fixation by repositioning and fixing the one or more bone fragments into normal alignment; producing, at a point-of-care, a three-dimensional model of the virtually generated support device in a form that can be applied to the patient; applying the three-dimensional model generated at the point-of-care to the one or more reference pins inserted into the one or more bone fragments of the patient in the first configuration; and simultaneously re-positioning and fixing the one or more bone fragments into normal alignment.
 2. The method of claim 1, wherein the method comprises inserting two or more reference pins.
 3. The method of claim 2, wherein the two or more reference pins are threaded.
 4. The method of claim 1, wherein the reference pins are manufactured from a radiolucent material.
 5. The method of claim 4, wherein the one or more reference pins are manufactured from a plastic-based material.
 6. The method of claim 5, wherein the plastic-based material is selected from a group consisting of PEEK, polysulfone, polycarbonate, glass fiber, graphite fiber, polyetherimide, polyethersulfone, polyphenylsulfone, polyphenylsulfide and combinations thereof.
 7. The method of claim 1, wherein the method further comprises: attaching one or more scanning locators to the one or more reference pins positioned in the first configuration at a proximal end.
 8. The method of claim 7, wherein the one or more scanning locators are manufactured from a radiopaque material.
 9. The method of claim 8, wherein the radiopaque material is selected from a group consisting of stainless steel, aluminum, titanium, silver, bismuth, and tantalum materials, radiopaque composite materials or combinations thereof.
 10. The method of claim 1, wherein the method further comprises: locking the three-dimensional model to the one or more reference pins inserted into the one or more bone fragments of the patient in the first configuration.
 11. The method of claim 1, wherein the image data is captured using an image capture device.
 12. The method of claim 11, wherein the image capture device is an X-ray, MRI, CT, CBCT, or ultrasound device.
 13. The method of claim 1, wherein the three-dimensional model produced at the point-of-care is produced using a 3D printing device or a desktop CNC mill.
 14. The method of claim 1, wherein the method further comprises: adding additional apertures during virtual generation of the support device at the discretion of a surgeon. 